Corporate Profile

Prepping for the Clinic

BioLineRx prefers to in-license early-stage products as they allow much more flexibility and creativity in the development process.

BioLineRx is a drug development company focused on advancing research products into the clinic. The company was formed in 2003 to bring Israeli biotech to global attention, but has since expanded its interests and now in-licenses preclinical and early-stage clinical projects—wherever they are found—and advances them until they are ready for out-licensing and commercialization.

Many of the in-licensed projects began within Israel’s leading universities. “Israel is known for its world-leading early-stage research. However, a relatively low number of drugs on the market have originated from Israeli technology. BioLineRx was founded to bridge this gap,” Kinneret Savitsky, Ph.D., CEO of BioLineRx, explains. To do that, the company maintains strategic relationships “…with all the leading universities in Israel, as well as substantial connections with many incubators and biotech companies.”

It’s a win-win approach. The inventors gain experienced managers and drug developers, thus giving their projects a better chance of success than they may find in a typical start-up environment. And for BioLineRx, the close relationships enable access to these projects from leading academic institutions and young companies while they can be shaped most easily to meet regulatory and commercial demands.

Generally, BioLineRx considers in-licensing only projects with in vivo efficacy data and information regarding the mechanism of action (MOA). Additional criteria include the strength and age of the intellectual property, market need, clinical development timelines, and costs.

“We believe that our competitive advantage comes best into play when applied to early-stage projects,” Dr. Savitsky says. BioLineRx’ focus on early-stage projects allows much more flexibility and creativity in the development process. “In many projects, we make significant changes in the route of administration or in the chemistry, manufacturing, and control of the compound.”

BioLineRx also sometimes has the opportunity to alter the regulatory path the drug takes toward approval. For example, Dr. Savitsky says, “BL-1040, an asset to prevent ventricular remodeling after an acute myocardial infarction, was considered a drug when we in-licensed the program. Our development team, after much research, obtained a device designation from the regulatory authorities, and also changed the route of administration to an intra-coronary injection via catheter. Because we were able to implement this change at the preclinical stage, we saved substantial time and resources and increased the value of the asset.” It was out-licensed to Ikaria in 2009.

In-Licensing

In 10 years, BioLineRx has screened more than 2,000 compounds and introduced more than 70 candidates to its scientific advisory board for consideration. Of these candidates, it has initiated 43 therapeutic candidate programs and terminated 32 feasibility programs. Eleven programs currently are in development.

Once a project is in-licensed, “It is in our interest to keep the inventors involved to a significant extent in the project. For example, they have the expertise in areas such as MOA, early efficacy models, etc. Therefore, we often perform MOA and other basic experiments in the scientist’s lab with our close involvement. Other more advanced experiments, including in vivo efficacy models, are done either internally at BioLineRx or by outsourcing,” Dr. Savitsky says.

In addition to preclinical projects, “We also are looking at more advanced projects in the early clinical stages of development, as we believe our expertise can be utilized to increase project value and align it with clinical and market needs. For example, we in-licensed BL-8040 in 2012, which was a Phase II-ready asset for acute myeloid leukemia and other hematological cancers,” Dr. Savitsky says.

During the past few years, BioLineRx has expanded its focus beyond academia and is screening increasing numbers of projects from industry, and also from countries other than Israel. “For example, BL-5010 for the nonsurgical removal of skin lesions was in-licensed from an Israeli company (rather than academia),” Dr. Savitsky says. “In addition, although our ‘sweet spot’ initially was Israel, we currently have three projects (out of 11) that were sourced outside of Israel. For example, BL-7010 for celiac disease was in-licensed in 2011 from Univalor, a tech transfer office that represents several academic institutions in Montreal.”

The company’s main projects currently include therapeutics to treat ventricular remodeling associated with acute myocardial infarctions, skin lesions, celiac disease, and acute myeloid leukemia and other hematological cancers.

Out-Licensing

While projects are being advanced at BioLineRx, its business development team communicates with pharmaceutical companies regularly to gauge their interest in commercialization. This steady communication with pharma companies helps keep BioLineRx on their radar screens and also provides interested commercialization partners valuable input on the development process. These insights help BioLineRx fine-tune the projects so they are better aligned with commercialization goals and, therefore, are more valuable to potential partners.

Out-licensing is not a simple hand-off. Instead, “Our out-licensing arrangements require our involvement on a regular basis, primarily through a joint development committee, where the development plan and issues are discussed and decisions are made,” Dr. Savitsky says.

The regular pipeline updates have evolved into long-term relationships with many global pharma companies. “As the company has matured, we also have become more flexible regarding the exit point,” Dr. Savitsky points out. “We now are open to earlier-stage partnering deals, as well as regional deals. For example, we recently out-licensed BL-8030 (a preclinical asset for hepatitis C) to CTTQ, the leading Chinese pharma company in the liver disease space, in a regional deal for China and Hong Kong.”

For certain programs, BioLineRx is willing to continue development to a later stage —conducting pivotal studies, for instance—thereby retaining a larger piece of the economic pie. “For example, we are currently planning a pivotal CE-mark registration study for BL-5010, which is expected to commence in the fourth quarter of this year,” Dr. Savitsky says.

The company’s in-house expertise has been honed by its own internal screening and development work, and by business expertise in areas specific to commercialization. The company has more than 300 consultant agreements in place to provide deep subject-matter expertise as needed. “Furthermore, our project managers themselves have specific expertise in the relevant therapeutic area,” Dr. Savitsky adds.

BioLineRx

Focus: BioLineRx in-licenses promising molecules, mainly from academic institutions and biotech incubators, and prepares them for commercial development before out-licensing them to medium-size and large pharma companies.

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